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Skin Cancer Prevention Strategies for Skin Cancer (RISE-UP Trial)
Phase 3
Recruiting
Led By Yelena Wu, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Report having at least one sunburn in the last year
Report intentional or unintentional outdoor tanning "sometimes," "often," or "always"
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention
Awards & highlights
RISE-UP Trial Summary
This trial aims to identify intervention approaches that help people avoid sunburn and motivate sun protection, by testing 3 personalized risk components over 1 year with 528 people.
Who is the study for?
This trial is for undergraduate students over 18 who have tanned indoors once in the past year, experienced at least one sunburn last year, and use sunscreen or other sun protection infrequently. They must also engage in outdoor tanning to some degree. Those with a history of skin cancer or who don't read/speak English cannot participate.Check my eligibility
What is being tested?
The study tests whether UV photos, an action plan for sun protection, and MC1R genetic testing can prevent sunburns among undergraduates. Participants will be assessed four times over 15 months to see which methods work best alone or combined.See study design
What are the potential side effects?
Since this trial involves non-invasive interventions like education and planning without medical treatments, significant side effects are not expected. However, participants may experience discomfort from confronting personal risk factors for skin cancer.
RISE-UP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had at least one sunburn in the past year.
Select...
I sometimes, often, or always tan outdoors intentionally or unintentionally.
Select...
I am 18 years old or older.
RISE-UP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Sunburn Occurrence
Secondary outcome measures
Change in Intentional Tanning Behaviors
Change in Sun Protection Behaviors
Change in UVR Exposure
+1 moreRISE-UP Trial Design
8Treatment groups
Experimental Treatment
Group I: Education + UV Photo + MC1R TestExperimental Treatment3 Interventions
Students in this intervention will receive education on skin cancer and prevention strategies, receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system, and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.
Group II: Education + UV PhotoExperimental Treatment2 Interventions
Students in this intervention will receive education on skin cancer and prevention strategies and receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system.
Group III: Education + MC1R TestExperimental Treatment2 Interventions
Students in this intervention will receive education on skin cancer and prevention strategies and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.
Group IV: Education + Action Plan + UV Photo + MC1R TestExperimental Treatment4 Interventions
Students in this intervention will receive education on skin cancer and prevention strategies, complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure, receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system, and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.
Group V: Education + Action Plan + UV PhotoExperimental Treatment3 Interventions
Students in this intervention will receive education on skin cancer and prevention strategies, complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure, and receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system.
Group VI: Education + Action Plan + MC1R TestExperimental Treatment3 Interventions
Students in this intervention will receive education on skin cancer and prevention strategies, complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure, and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.
Group VII: Education + Action PlanExperimental Treatment2 Interventions
Students in this intervention will receive education on skin cancer and prevention strategies and complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure.
Group VIII: EducationExperimental Treatment1 Intervention
Students in this intervention will receive education on skin cancer and prevention strategies.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Education
2017
N/A
~4770
Action Plan
2020
N/A
~390
UV Photo
2017
N/A
~170
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,161 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,672,054 Total Patients Enrolled
Yelena Wu, PhDPrincipal InvestigatorUniversity of Utah
5 Previous Clinical Trials
31,086 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used indoor tanning at least once in the past year.I had at least one sunburn in the past year.I have had skin cancer before.You rarely use sunscreen and other sun protection methods like hats or staying in the shade.I sometimes, often, or always tan outdoors intentionally or unintentionally.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Education + MC1R Test
- Group 2: Education + Action Plan + UV Photo + MC1R Test
- Group 3: Education + Action Plan
- Group 4: Education
- Group 5: Education + UV Photo
- Group 6: Education + Action Plan + MC1R Test
- Group 7: Education + UV Photo + MC1R Test
- Group 8: Education + Action Plan + UV Photo
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA approved Education + UV Photo as a medical treatment?
"We rate the safety of Education + UV Photo as a 3, signifying that numerous studies have demonstrated its efficacy and multiple trials have verified its safety."
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